Long-term toxicity and carcinogenicity test of ammonia-process caramel colouring given to B6C3F1 mice in the drinking-water.

Caramel colouring (ammonia process) was given at levels of 0 (control), 1.25 and 5.0% in the drinking-water to groups of 50 male and 50 female mice for 96 wk, and then all all the animals were maintained without caramel for a further 8 wk. Males given 5.0% caramel showed increased cumulative mortality from wk 100 to the end of the experiment. The white blood cell count in treated males was significantly elevated in a dose-related manner. However, these changes were not considered to be biologically significant. There were no treatment-related effects on clinical signs, body or organ weights, results of urine analyses, or histological features. Therefore, this study did not demonstrate any carcinogenic effect of caramel on mice at levels of up to 5.0% in the drinking-water.